Nandrolone Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2010-09-08)
Oldest Current Product
2000-01-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\NANDROLONE
FDAOB
INJECTION\INJECTION\NANDROLONE DECANOATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\NANDROLONE DECANOATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\NANDROLONE

product(s) by strength(s)

nandrolone 200 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170790ANDAAmerican Regent, Inc.2000-01-01NANDROLONE DECANOATEINTRAMUSCULARINJECTION, SOLUTIONANDA0912523f059e04-1ebc-40bb-a49c-f9d90d41b1cb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086385NANDROLONE DECANOATETrueWATSON LABORATORIES INC1984-01-13ANDA086385_001
2ANDA086598NANDROLONE DECANOATETrueWATSON LABORATORIES INC1984-01-13ANDA086598_001
3ANDA087519NANDROLONE DECANOATETrueAKORN INC1983-09-28ANDA087519_001
4ANDA087598NANDROLONE DECANOATETrueWATSON LABORATORIES INC1983-10-06ANDA087598_001
5ANDA087599NANDROLONE DECANOATETrueWATSON LABORATORIES INC1983-10-06ANDA087599_001
6ANDA088128NANDROLONE DECANOATETrueWATSON LABORATORIES INC1983-12-05ANDA088128_001
7ANDA088290NANDROLONE DECANOATETrueABRAXIS PHARMACEUTICAL PRODUCTS1983-10-03ANDA088290_001
8ANDA088317NANDROLONE DECANOATETrueABRAXIS PHARMACEUTICAL PRODUCTS1983-10-14ANDA088317_001
9ANDA088554NANDROLONE DECANOATETrueWATSON LABORATORIES INC1986-02-10ANDA088554_001
10ANDA091252NANDROLONE DECANOATEPHARMAFORCE INC2010-08-30ANDA091252_001
11NDA013132DECA-DURABOLINTrueASPEN GLOBAL INC1986-06-12NDA013132_001, NDA013132_002, NDA013132_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA086385_001discontinuedNANDROLONE DECANOATE (50MG/ML)INJECTIONFalse1984-01-13NANDROLONE DECANOATE
2ANDA086598_001discontinuedNANDROLONE DECANOATE (100MG/ML)INJECTIONFalse1984-01-13NANDROLONE DECANOATE
3ANDA087519_001discontinuedNANDROLONE DECANOATE (100MG/ML)INJECTIONFalse1983-09-28NANDROLONE DECANOATE
4ANDA087598_001discontinuedNANDROLONE DECANOATE (50MG/ML)INJECTIONFalse1983-10-06NANDROLONE DECANOATE
5ANDA087599_001discontinuedNANDROLONE DECANOATE (100MG/ML)INJECTIONFalse1983-10-06NANDROLONE DECANOATE
6ANDA088128_001discontinuedNANDROLONE DECANOATE (200MG/ML)INJECTIONFalse1983-12-05NANDROLONE DECANOATE
7ANDA088290_001discontinuedNANDROLONE DECANOATE (100MG/ML)INJECTIONFalse1983-10-03NANDROLONE DECANOATE
8ANDA088317_001discontinuedNANDROLONE DECANOATE (200MG/ML)INJECTIONFalse1983-10-14NANDROLONE DECANOATE
9ANDA088554_001discontinuedNANDROLONE DECANOATE (50MG/ML)INJECTIONFalse1986-02-10NANDROLONE DECANOATE
10ANDA091252_001RXNANDROLONE DECANOATE (200MG/ML)INJECTIONTrue2010-08-30NANDROLONE DECANOATE
11NDA013132_001discontinuedNANDROLONE DECANOATE (50MG/ML)INJECTIONFalse1986-06-12DECA-DURABOLIN
12NDA013132_002discontinuedNANDROLONE DECANOATE (100MG/ML)INJECTIONFalse1986-06-12DECA-DURABOLIN
13NDA013132_003discontinuedNANDROLONE DECANOATE (200MG/ML)INJECTIONFalse1986-06-12DECA-DURABOLIN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
13f059e04-1ebc-40bb-a49c-f9d90d41b1cb (view SPL)NANDROLONE DECANOATE INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.2010-09-081005170790

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII